At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 38 enrolled

Drug / intervention

CLAG Regimen +1 moredrug

Likely dose

CLAG Regimen 5 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00955916

NCT00955916Phase 2Completed

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A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Relapsed or Refractory Acute Myeloid Leukemia

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Aug 10, 2009·Updated Jun 27, 2014

In Brief

A Phase 2 clinical trial evaluating CLAG Regimen and Gleevec® for Leukemia. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLeukemia

CountriesUnited States

CollaboratorsNovartis

Timeline

Phase 2CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartAug 2009

First PostedAug 2009

Primary CompletionDec 2012

Study CompletionMay 2014

TodayJul 2026

First PostedAug 10, 2009

Enrollment StartAug 1, 2009

Primary CompletionDec 1, 2012

Study CompletionMay 1, 2014

TodayJul 2, 2026

Enrollment to primary: 3.3 yearsPosted 16.9 years ago

Interventions

CLAG Regimendrug

The CLAG regimen consisted of: Cladribine, 5 mg/m\^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m\^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine.

Gleevec®drug

Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).